Role & responsibilities

- Execute analytical method development, optimization, validation, verification, and method transfer activities for oncology formulations.
- Perform analytical testing including assay, related substances, dissolution, content uniformity, residual solvents, and stability studies.
- Conduct forced degradation studies and support development of stability-indicating analytical methods.
- Operate analytical instruments such as HPLC, UPLC, GC, UV-Visible Spectrophotometer, and Dissolution Apparatus.
- Prepare and maintain analytical protocols, reports, laboratory notebooks, raw data, and technical documents.
- Review analytical results, identify deviations/trends, and support investigations related to OOS/OOT results.
- Coordinate with Formulation R&D;, QA, Regulatory Affairs, Production, and other cross-functional teams for project execution.
- Ensure compliance with cGMP, GLP, GDP, data integrity, and oncology safety procedures.




- Support equipment calibration/qualification activities and maintain laboratory housekeeping as per EHS guidelines.

Educational Qualification

- M.Pharm/MS (Pharmaceutical Analysis) or equivalent qualification from a recognized university.

Technical Competencies

- Hands-on experience in analytical method development and validation for pharmaceutical products.
- Proficiency in handling HPLC, UPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, and other analytical instruments.
- Knowledge of ICH guidelines, pharmacopoeial requirements (USP/EP/IP), and regulatory expectations for regulated markets.
- Understanding of impurity profiling, forced degradation studies, stability studies, and analytical data interpretation.
- Familiarity with analytical method transfer, CMC documentation support, and data integrity requirements.

Interested candidates can apply or share their resume on [email protected]

📌 Senior Executive - ARD Oncology (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai